NZ563057A

NZ563057A - Heat treating a biological site in a patient's body

Info

Publication number: NZ563057A
Application number: NZ563057A
Authority: NZ
Inventors: James Panos; Jose Luis Cincunegui
Original assignee: Cathrx Ltd Acn 089 310 421
Priority date: 2006-11-29
Filing date: 2007-11-01
Publication date: 2009-03-31
Also published as: US8100895B2; ES2349063T3; AU2007231704A1; AU2007231704B2; JP2008136864A; US20080154255A1; ATE478622T1; CN101288598A; CA2610645A1; EP1927323A1; JP5120806B2; DE602007008665D1; EP1927323B1

Abstract

A system, method and apparatus for a heat treatment device is provided. The device includes: a transformer having a primary winding and a secondary winding, where the secondary winding has at least one tap, to provide a patient reference and at least two sources of radio frequency (RF) energy, the two sources of RF energy being out of phase with each other, and a group of electrodes connected to the sources of RF energy provided by the secondary winding to be simultaneously energised, the arrangement being such that there are more active electrodes connected to one of the sources of RF energy than the other of the sources of RF energy with the energy supplied to one active electrode being out of phase with the energy supplied to an adjacent active electrode.

Description

Patents Form No 5 *10054753908* NEW ZEALAND Patents Act 1953 S 3 0 5 7 CATHRX LTD COMPLETE SPECIFICATION Invention Title: Heat treating a biological site in a patient's body I/We CathRx Ltd, ACN 089 310 421, of Suite G16, National Innovation Centre Australian Technology Park, Eveleigh, New South Wales, 1430, Australia; hereby declare the invention, for which we pray that a patent may be granted to us, and the method by which it is performed, to be particularly described in and by the following statement:- intellectual property office of n.z. -1 NOV 2007 received <14/12 $008 WED 10:21 FAI 61 2 8231 1099 FB RICE & CO 0006/040 "Heat treating a biological site in a patient's body" Cross-Reference to Related Applications The present application claims priority from United States of America 5 Provisional Patent Application No 60/872,021 filed on 29 November 2006, the contents of which are incorporated herein by reference.

Field This invention relates, generally, to the heat treatment of a biological site in a 10 human or animal body. More particularly, the invention relates to a system for, and a method of, heating a biological site in a patient's body to produce at least one lesion at the site or for the treatment of pain management. ' Background Electromagnetic energy, in the form of radio frequency (RF) energy, is used to produce lesions at a biological site in the human or animal body for many purposes such as, for example, for cardiac ablation purposes, for tumour ablation, etc. RF energy Can also be used for heating a site for the treatment of pain management. To apply the RF energy at the required site in the body, an electrode is used as a conductor with an 20 electrode tip forming a first terminal of the circuit and a back patch beneath the patient's body forming a return electrode for the circuit so that, "when the electrode tip is brought into contact with the site, a closed circuit is formed. A problem with this arrangement is that the impedance of the patient's body is high resulting in dissipation of the RF energy through the patient's body rather than being concentrated at the site. 25 Traditionally lesions have been produced at a site using a single active electrode system. The RF energy is applied to a small electrode tip towards the end of a catheter with a return path being made via the patient's body.

Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is solely for the purpose of providing a 30 context for the present invention. It is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application.

INTELLECTUAL PROPERTY OFFICE OF N.Z. 2 ii DEC 2008 received M/12 £008 WED 10:22 FAX 61 2'8231 1099 FB RICE & CO @007/040 3 Summary According to a first aspect of the invention, there is provided a system foi heating a site in a patient's body, the system including a transformer having a primary winding and a secondary winding, the secondary 5 winding having at least one tap to provide a patient reference and at least two sources of radio frequency (RF) energy, the two sources of RF energy being out of phase with each other; and a group of electrodes connected to the sources of RF energy provided by the secondary winding to be simultaneously energised, the arrangement being such that 10 there are more active electrodes connected to one of the sources of RF energy than the other of the sources of RF energy with the energy supplied to one active electrode being out of phase with the energy supplied to an adjacent active electrode.

At least periodically, the group of active electrodes may comprise an odd number of electrodes with a sub-group of an even number of active electrodes being 15 connected to one of the sources of RF energy and a sub-group of an odd number of active electrodes being connected to the other of the sources of RF energy and the active electrodes of the sub-groups alternating with one another along a length of a catheter carrying the electrodes. More particularly, the group of electrodes may comprise at least three active electrodes which are energised simultaneously with the 20 energy supplied to one sub-group comprising two outer electrodes of the group of three active electrodes being in phase with each other but out of phase with the energy supplied to another sub-group comprising a single, inner, or middle, active electrode arranged between the two outer electrodes of the one sub-group.

The system may include a switching arrangement interposed between the 25 secondary winding of the transformer and the group of electrodes periodically to change the configuration of active electrodes connected to the sources of RF energy.

It will be appreciated that it is not necessary that it is always the same active electrode that is connected to the one sub-winding. In practice, this may not in fact be the case. For example, in a 3 electrode system, electrode 1 may initially be connected 30 to the first sub-windings and electrode 3 may be connected to the second sub-winding. After a predetermined period of time, electrodes 1 and 3 may be connected together to the first sub-winding under the action of the switching arrangement and electrode 2 may be connected to the second sub-winding.

The system may include a monitoring device associated with each electrode for 35 monitoring the energy supplied to each active electrode. The monitoring device may be a temperature sensing device, such as a thermocouple or thermistor, for monitoring intellectual property OFFICE OF N.Z. 2 <i DEC 2008 *24/12 f008 WED 10:23 FAX 61 2 8231 1099 FB RICE & CO IS008/040 4 the temperature of its associated active electrode. In addition, monitoring devices may also be arranged between adjacent electrodes. The monitoring devices may be connected to the switching arrangement, the switching arrangement being responsive to a monitored parameter of each active electrode for feedback control of the magnitude 5 of RF energy to be supplied to the active electrodes and/or for switching between configurations of electrodes connected to the sources of RF energy. For example, the switching arrangement may select the appropriate thermocouple, i.e. the thermocouple associated with the hottest active electrode, in order to control the magnitude of the RF energy to be delivered to the electrodes. Other monitoring devices may include 10 pressure sensors, fibreoptic devices, impedance measuring devices, or the like.

The system may include an energy generator for generating the RF energy, the primary winding of the transformer being connected to an output of the energy generator. The generator may be responsive to the switching arrangement and to the monitored parameter of the active electrodes, as monitored by the monitoring devices, 15 to control the RF energy supplied to the active electrodes.

The transformer may have a 1:1 ratio between the primary winding and the secondary winding. The tap may be a centre tap to provide two sub-windings which act as energy sources with the energy supplied by the sources being 180° out of phase with respect to each other.

In an embodiment, at least one of the electrodes connected to each source of RF energy may not be active at the time that at least one other electrode connected to that source of RF energy is active.

According to a second aspect of the invention, there is provided a system for heating a site in a patient's body, the system including 25 a transformer having a primary winding and a secondary winding, the secondary winding having at least one tap to provide a patient reference and at least two'sources of radio frequency (RF) energy, the two sources of RF energy being out of phase with each other; and a plurality of active electrodes connected to the sources of RF energy provided 30 by the secondary winding to be simultaneously energised, with multiple active electrodes being connected to one of the sources of RF energy and a different number of active electrodes being connected to the other source of RF energy and the energy supplied to each of the multiple active electrodes being of the same phase but out of phase with the energy supplied to each of the different number of active electrodes. intellectual property OFFICE OF N.Z. 2 4 DEC 2008 RECEIVED t24/12 3008 WED 10 :24 FAX 61 2 8231 1099 FB RICE & CO 0009/040 The amplitude of the energy supplied to each of the multiple active electrodes may "be less than the amplitude of the energy supplied to each of the different number of active electrodes.

The system may include an energy generator for generating the RF energy, the 5 primary winding of the transformer being connected to an output of the energy generator. The generator may be responsive to the switching arrangement and to a monitored parameter of the electrodes, as monitored by a monitoring device associated with each electrode, to control the RF energy supplied to the electrodes. The monitored parameter of each electrode may be a temperature of each electrode. Thus, the 10 monitoring device associated with each electrode may be a temperature sensing device, such as a thermocouple or thermistor.

The transformer may have a 1:1 ratio between the primary winding and the secondary winding. The tap may be a centre tap to provide two sub-windings which act as energy sources with the energy supplied by the sources being 180° out of phase 15 with respect to each other.

At least one active electrode may be connected to one sub-winding and at least two active electrodes may be connected to the other sub-winding.

According to a third aspect of the invention, there is provided a method of operating a heat-treatment device, the method including 20 providing a transformer having a primary winding and a secondary winding, the secondary winding having at least one tap to provide a reference and at least two sources of radio frequency (RF) energy, the two sources of RF energy being out of phase with each other and connecting a group of electrodes to the sources of RF energy provided by the secondary winding to be simultaneously energised, the arrangement 25 being such that there are more active electrodes connected to one of the sources of RF energy than the other of the sources of RF energy; and supplying energy to one active electrode and to an adjacent active electrode, with the energy supplied to the one active electrode being out of phase with the energy supplied to the adjacent active electrode.

The method may include, at least periodically, selecting an odd number of active electrodes to constitute the group of electrodes, connecting a sub-group comprising an even number of active electrodes to one of the Sources of RF energy and a sub-group comprising an odd number of active electrodes to the other of the sources of RF energy, with the active electrodes of the sub-groups alternating with one another along a length 35 of a catheter carrying the electrodes. More particularly, the method may include selecting the group of electrodes to comprise at least three active electrodes which are INTELLECTUAL PROPERTY OFFICE OF N.2. 24 DEC received] *24/12 f008 WED 10:24 FAX 61 2 8231 1099 KB RICE & CO ®010/040 6 energised simultaneously with the energy supplied to a sub-group comprising two outer active electrodes of the group of three electrodes being in phase with each other but out of phase with the energy supplied to a sub-group comprising a single, inner active electrode arranged between the two outer electrodes of said one sub-group.

The method may include interposing a switching arrangement between the secondary winding of the transformer and the group of electrodes periodically to change the configuration of electrodes connected to the sources of RF energy.

Further, the method may include monitoring the energy supplied to each active electrode. The method may include monitoring and controlling the energy supplied to 10 each active electrode by monitoring the temperature of each electrode and selecting the hottest electrode for feedback control.

The method may include connecting at least one active electrode to one sub-winding and connecting at least two active electrodes periodically to the other sub-winding.

The method may include, periodically, having the same number of electrodes connected to each source of RF energy.

In an embodiment, the method may include de-activating at least one of the electrodes connected to each source of RF energy at the time that at least one other electrode connected to that source of RF energy is active.

The method may include activating a sub-group of electrodes of the group of the electrodes while the remaining electrodes of the group of electrodes are de-activated and, after a period of time, activating a different sub-group of electrodes. Preferably, the method includes selecting the same number of electrodes to constitute each activated sub-group of electrodes.

According to a fourth aspect of the invention, there is provided a . method of operating a heat-treatment device, the method including providing a transformer having a primary winding and a secondary winding, the secondary winding having at least one tap to provide a reference and at least two sources of radio frequency (RF) energy, the two sources of RF energy being out of 30 phase with each other,and connecting a plurality of electrodes to the sources of RF energy provided by the secondary winding to be simultaneously energised, with multiple active electrodes being connected to one of the sources of RF energy and a different number of active electrodes being connected to the other source of RF energy; and intellectual property office of n.z. 2 4 DEC 2008 RECEIVED ,24/12 ?008 WED 10:25 FAX 61 2 8231 1099 FB RICE & CO ®011/040 Supplying energy to each of the multiple active electrodes in the same phase and supplying energy to each of the different number of active electrodes out of phase with the energy supplied to the multiple active electrodes.

The method may include supplying energy to each of the multiple active S electrodes which has an amplitude less than the amplitude of the power supplied to each of the different number of active electrodes.

The method may include connecting at feast one active electrode to one sub-winding and connecting at least two active electrodes to the other sub-winding.

Brief Description of the Drawings A preferred embodiment of the invention will be described hereinafter, by way of example only, with reference to the accompanying drawings, in which: Fig. 1 shows a schematic block diagram of an embodiment of a system for 15 heating a biological site in a patient's body, the system being shown in a first configuration; and Fig. 2 shows a schematic block diagram of the system in a second configuration.

Detailed Description of Exemplary Embodiments In the drawings, reference numeral 10 generally designates a system, in accordance with an embodiment of the invention, for heating a site in patient's body. The system 10 includes a generator 12 for generating electromagnetic energy, more particularly, radio frequency (RF) energy.

The generator 12 is in communication with a transformer 14. The transformer 25 14 has a core 14.1, a primary winding 14.2 and a secondary winding 14.3. The secondary winding 14.3 of the transformer 14 is a centre tapped transformer having a centre tap 16, The centre tap 16 is connected via a return line 18 to the generator 12.

The centre tap creates two sub-windings 22, to each of which at least one active electrode 24 of a catheter 26 is connectable. By "active" is meant that, unless the 30 context clearly indicates otherwise, the electrode is used to impart energy to the site.

The arrangement of the sub-windings 22 is such that, due to the centre tap 16, energy supplied by one sub-winding 22 is 180° out of phase with the energy supplied by the other sub-winding 22.

The transformer 14 makes use of a 1:1 ratio between the primary winding 14.2 35 and the secondary winding 14.3. In addition, the materials used in the transformer 14 are selected to be capable of withstanding energy levels and frequencies involved in ... i intellectual property OFFICE OF N.Z. 2 4 DEC 2008 RECEIVED *24/12 1908 WED 10:26 FAI 61 2 8231 1099 FB RICE & GO @012/040 8 ablative therapies. The transformer 14 and the materials used are optimised to ensure maximum transfer of energy from the transformer 14 to the active electrodes 24.

Suitable materials for the transformer include nickel-zinc or manganese-zinc ferrites for the core 14.1 of the transformer 14, in particular F8, F12 and F14 ferrites.

These materials are able to operate at the required frequencies and have the necessary high initial permeability and high saturation flux. The dimension of the core, the number of turns of the windings 14.2 and 14.3 and the diameter of the windings are selected so that the transformer 14 has low insertion losses to ensure efficient transfer of energy.

The primary winding 14,1 of the transformer 14 is matched to the output impedance of the generator 12. The generator 12 has an output impedance of between about 30 and 300 ohms. If necessary, a series resistor and/or a parallel capacitor can be included to effect impedance matching.

The active electrodes 24 are connected to the secondary winding 14.3 of the 15 transformer 14 via a switching arrangement 28. In addition, each active electrode 24 has a thermocouple, illustrated schematically by each line 30, connected to the switching arrangement for the control of energy to the active electrodes 24 by the system 10. The system 10 also includes a thermocouple 30 connected between adjacent electrodes 24 for more accurate temperature control, The system 10 is intended for use in the production of lesions at a site in a patient's body for treating various disorders such as atrial fibrillation, ventricular tachycardia, tumour ablation, or the like or for heat treating the site in the treatment of pain management. In the case of pain management, it may not be necessary that lesions are actually created, rather that heat treating of the site effects management of the pain. 25 In the case of atrial fibrillation, abnormal electrical impulse activity in the tissue gives rise to irregular heart rhythms. This necessitates the formation of a large number of spot lesions. This is a time consuming and difficult process and may result in excessive charring of the tissue. It is also necessary that the spots overlap to ensure that the undesirable signal path is interrupted. Thus accurate placement of the ablating 30 electrode of a catheter is required. Also, use is made of a back plate as a return electrode resulting in excessive dissipation of energy through the patient's body.

If it were possible to form, longer lesions, the number of lesions to be formed can be reduced thereby improving the accuracy of the technique and minimising damage to the tissue.

In use, in an initial configuration, the electrodes 24 are connected to the secondary winding 14.3 of the transformer 14 in the configuration shown in Fig. 1 of intellectual property ofrce of n.z. 2 4 DEC 2008 received 24/12^2008 WED 10:27 FAX 61 2 8231 1099 FB RICE & CO @013/040 9 the drawings. Thus, a sub-group comprising two outer electrodes 24 of a group of three electrodes 24 is connected to one of the sub-windings 22 with a sub-group comprising the inner electrode 24 of the group of three electrodes 24 being connected to the other sub-winding 22. The energy supplied to each outer electrode 24 is half that of the 5 energy supplied to the inner electrode 24. In addition, the energy supplied to the outer electrodes 24, while being in phase with each other, is out of phase with the energy supplied by the sub-winding 22 to the inner electrode 24. More particularly, the energy supplied to the outer electrodes 24 is 180° out of phase with the energy supplied to the inner electrode 24.

While this embodiment has been described with reference to the use of three active electrodes 24, it will be appreciated that any desired number of electrodes could be used. For example, a five active electrode system would have electrodes 1, 3 and 5 connected to one of the sub-windings 22 with a phase angle of the energy of 0° with electrodes 2 and 4 being connected to the other sub-winding 22 with a phase angle of 15 the energy of 180c'.

Using this arrangement of energising alternate electrodes of a group of electrodes, a longer, more confluent lesion is formed which concentrates the ablation to extend between inner ends of the outer electrodes 24 of the group of electrodes. The connection of electrodes I and 3 to the same phase is done using the switching 20 arrangement 28 and may incorporate a relay or a mechanical switch.

In a variation of this embodiment, the switching arrangement 28 includes a timing mechanism. Initially, energy is supplied to the site using the three active electrodes 24 (in this example) in the configuration shown in Fig. 1 of the drawings.

After a predetermined period of time, the switching of the electrodes changes so that 25 electrode 1 is connected to one of the sub-windings 22 and electrode 3 is connected to the other sub-winding 22 with electrode 2 not being connected to either sub-winding 22. With this arrangement, an even longer, confluent lesion is formed which extends over the entire length of the distance covered by the three electrodes. In other words, a lesion is formed up to outer ends of the outer electrodes 24 with a very rectangular 30 appearance and a more uniform depth than with a traditional, single electrode system.

The system 10 could also have a number of inactive electrodes connected to each sub-winding of the transformer 14. Thus, in another embodiment, a cascading-like effect can be imparted to a series of electrodes 24 for creating a longer lesion but with lower power consumption, Thus, for example, if one sub-winding 22 had three 35 electrodes 24 connected to it and the other sub-winding had two electrodes connected to it, the switching arrangement 28 could be configured to energise only three intellectual property offfce OF n.z.

Ik DEC 2008 received ,24/12 $008 WED 10:28 FAX 61 2 8231 1069 FB RICE & CO @014/040 electrodes 24 at any one time, In this embodiment, one active electrode 24 of one sub-winding 22 is interposed between two active electrodes both connected to the other sub-winding 22 so that the energy supplied to the middle active electrode 24 is 180° out of phase with the energy supplied to the two outer electrodes 24. The remaining 5 electrodes 24 connected to the sub-windings are not energised and are inactive.

Thus, electrodes 1 and 3 connected to the first sub-winding and electrode 2 connected to the second sub-winding are energised initially and are active with electrodes 4 and 5 being de-energised and inactive. After a period of time, for example, 5 seconds, there is a "shift" of active electrodes. More particularly, electrode 10 1 is de-energised to become inactive, electrodes 2 and 4 are active and are connected to one sub-winding 22, electrode 3 is active and is connected to the other sub-winding 22 and electrode 5 remains de-energised. After yet a further period of time, for example, a further 5 seconds, there is a further "shift" of active electrodes. Thus, electrodes 1 and 2 are rendered inactive, electrodes 3 and 5 are active and are connected to the one sub-15 winding and electrode 4 is active and is connected to the other sub-winding.

In this way, a longer lesion can be formed with reduced power consumption. For example, instead of 50W to activate 5 electrodes simultaneously, only 30W is required to energise 3 electrodes at a time. While the procedure may take a little longer to perform, better depth control can be effected to create an improved lesion.

It will also be appreciated that the cascading effect need not move along by one electrode at a time. Two or more electrodes in the series can be activated and deactivated at a time. In addition, the cascading effect need not move in one direction only; switching of the cascading effect back and forth can be effected by the switching arrangement 28 to control lesion formation.

The switching arrangement 28 is configured to switch only once in an ablating period between the two configurations as shown in Figs. 1 and 2 of the drawings.

Instead, the switching arrangement 28 can be configured to switch periodically between the two configurations during an ablating period. The latter switching technique may be beneficial in enabling more accurate temperature control during the lesion 30 formation.

The switching arrangement 28 monitors the temperature of all the thermocouples 30 of the system 10 in real time. To coincide with each intermittent ablation configuration, the thermocouple 30 selected for control of RF energy is selected based on the location of most energy activity, i.e. the thermocouple reading 35 associated with the hottest electrode 24, The temperature of the hottest electrode 24 is fed back to the generator 12 by the switching arrangement The generator 12 then INTELLECTUAl PROPERTY OFFICE OF N.Z. 2 4 DEC 2008 RECEIVED .24/12 2008 WED 10:28 FAX 61 2 8231 1099 FB RICE & CO 11015/040 11 controls the energy delivered to all the electrodes 24 based on the temperature data received from the switching arrangement 12.

The centre tap 16 functions as a reference patch and the connection 18 functions as a return path of the system 10. The reference patch and the connection 18 of the 5 system 10 are used only in the event that the connection of the electrode/s 24 to one of the sub-windings 22 is lost. Apart from that energy transfer takes place between adjacent electrodes of the system 24 resulting in a more efficient use of the energy during an ablation or heat treatment process.

While the system 10 has been described with reference to a single electrode 24 10 constituting each electrode of a group connected to the secondary winding 14,3 of the transformer 14, it will be appreciated that each electrode 24 could comprise a number of sub-electrodes making up the electrode 24 . A further variation of the arrangement of these sub-electrodes could be to alternate the RF energy delivered to the sub-electrodes with respect to each other to assist in lesion formation.

It is an advantage of the invention that, because lower power is supplied to each electrode 24 than with a single ablating electrode system, there is less charring of the tissue.

As described above, longer, more confluent and uniform lesions are formed than using a single ablating electrode. This improves the likelihood of interrupting signal 20 paths in the tissue giving rise to the cardiac abnormalities or other abnormalities being treated.

Became lesion formation occurs between two electrodes, the inter-electrode impedance is much lower than that through a patient's body resulting in improved energy transfer between the electrodes 24 rather than dissipation of energy through the 25 patient's body. By avoiding such large dissipation of energy through the patient's body, it also reduces the risk of surface tissue burns to the patient in the event of a poor tissue-electrode interface at the patient reference patch location.

It is still another advantage of the invention that the use of at least three electrodes is of benefit in creating more uniform, confluent, linear lesions such as are 30 used in "Maze"-like procedures.

The system 10 is easy to implement due to the use of a centre tapped transformer rather than the need for any dedicated phase-shifting systems or mechanisms.

| INTELLECTUAL PROPERTY OFFICE OF N.Z. 2* DEC 2008 received .24/12 #008 TOD 10:29 FAX 61 2 8231 1099 FB RICE & CO @016/040 12 It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative 5 and not restrictive. intellectual property office of n.2. 2 4 DEC 2008 RECEIVED

Claims

<24/12 2008 WED 10:29 FAX 61 2 8231 1099 FB RICE & CO @017/040 33 THE CLAIMS DESCRIBING THE INVENTION ARE AS FOLLOWS:

1. A system for heating a site in a patient's body, the system including a transformer having a primary winding and a secondary winding, the secondary winding having at least one tap to provide a patient reference and at least two sources 5 of radio frequency (RF) energy, the two sources of RF energy being out of phase with each other; and a group of electrodes connected to the sources of RF energy provided by the secondary winding to be simultaneously energised, the arrangement being such that there are more active electrodes connected to one of the sources of RF energy than the 10 other of the sources of RF energy with the energy supplied to one active electrode being out of phase with the energy supplied to an adjacent active electrode.

2. The system of claim i in which, at least periodically, the group of electrodes comprises an odd number of active electrodes with a sub-group of an even number of 15 active electrodes being connected to one of the sources of RF energy and a sub-group of an odd number of active electrodes being connected to the other of the sources of RF energy and the active electrodes of the sub-groups alternating with one another along a length of a catheter carrying the electrodes. 20

3. The system of claim 2 in which the group of electrodes comprises at least three active electrodes which are energised simultaneously with the energy supplied to one sub-group comprising two outer active electrodes of the group of three electrodes being in phase with each other but out of phase with the energy supplied to a sub-group comprising a single, inner active electrode arranged between the two outer electrodes of 25 said one group.

4. The system of any one of the preceding claims which includes a switching arrangement interposed between the secondary winding of the transformer and the group of electrodes periodically to change the configuration of electrodes connected to 30 the sources of RF energy. 5, The system of claim 4 which includes a monitoring device associated with each electrode for monitoring the energy supplied to each active electrode. 35 6. The system of claim 5 in which the monitoring device is a temperature sensing device for monitoring the temperature of its associated active electrode.

INTELLECTUAL property office of n.z. 2 4 DEC 2008

RECEIVED .24/12 2008 WED 10:30 FAI 61 2 8231 1099 FB RICE & CO 11018/040 14

7. The system of claim 5 or claim 6 in which the monitoring devices are connected to the switching arrangement, the switching arrangement being responsive to a parameter of each active electrode, monitored by its associated monitoring device, for 5 feedback control of the magnitude of RF energy to be supplied to the electrodes and/or for switching between configurations of electrodes connected to the sources of RF energy.

8. The system of any one of claims 4 to 7 which includes an energy generator for 10 generating the RF energy, the primary winding of the transfonner being connected to an output of the energy generator.

9. The system of claim 8 in which the generator is responsive to the switching arrangement and to the monitored parameter of the active electrodes, as monitored by 15 the monitoring devices, to control the RF energy supplied to the active electrodes.

10. The system of any one of the preceding claims in which the transformer has a 1:1 ratio between the primary winding and the secondary winding. 20

11. The system of any one of the preceding claims in which the tap is a centre tap to provide two sub-windings which act as energy sources with the energy supplied by the sources being 180° out of phase with respect to each other.

12. The system of any one of the preceding claims in which at least one of the 25 electrodes connected to each source of RF energy is not active at the time that at least one other electrode connected to that source of RF energy is active.

13. A system for heating a site in a patient's body, the system including a transformer having a primary winding and a secondary winding, the secondary 30 winding having at least one tap to provide a patient reference and at least two sources of radio frequency (RF) eneTgy, the two sources of RF energy being out of phase with each other; and a plurality of electrodes connected to the sources of RF energy provided by the secondary winding to be simultaneously energised, with multiple active electrodes 35 being connected to one of the sources of RF energy and a different number of active electrodes connected to the other source of RF energy and the energy supplied to each INTELLECTUAL PROPERTY OFFICE OF N.Z. 2 4 DEC 2008 received •24/12 2008 TOD 10:31 FAX 61 2 8231 1099 FB RICE & CO @019/040 15 of the multiple active electrodes being of the same phase but out of phase with the energy supplied to each of the different number of active electrodes,

14. The system of claim 13 in which the amplitude of the energy supplied to each of 5 the multiple active electrodes is less than the amplitude of the energy supplied to each of the different number of active electrodes.

15. The system of claim 13 or claim 14 which includes an energy generator for generating the RF energy, the primary winding of the transformer being connected to 10 an output of the energy generator.

16. The system of claim 15 in which the generator is responsive to the switching arrangement and to a monitored parameter of the electrodes, as monitored by a monitoring device associated with each electrode, to control the RF energy supplied to 15 the active electrodes.

17. The system of any one of claims 13 to 16 in which the transformer has a 1:1 ratio between the primary winding and the secondary winding. 20

18. The system of any one of claims 13 to 17 in which the tap is a centre tap to provide two sub-windings which act as energy sources with the energy supplied by the sources being 180° out of phase with respect to each other.

19. The system of claim 18 in which at least one active electrode is connected to one 25 sub-winding and at least two active electrodes are connected to the other sub-winding.

20. A method of operating a heat-treatment device, the method including providing a transformer having a primary winding and a secondary winding, the secondary winding having at least one tap to provide a reference and at least two 30 sources of radio frequency (RF) energy, the two sources of RF energy being out of phase with each other, and connecting a group of electrodes to the sources of RF energy provided by the secondary winding to be simultaneously energised, the arrangement being such that there are more active electrodes connected to one of the sources of RF energy than the other of the sources of RF energy; and

INTELLECTUAL PROPERTY office of N.Z. 21, DEC 2008

RECEIVED •24/12*2008 WED 10:31 FAX 61 2 8231 1099 FB RICE & CO;SJ020/040;16;supplying energy to one active electrode and to an adjacent active electrode, with the energy supplied to the one active electrode being out of phase with the energy supplied to the adjacent active electrode,;5 21. The method of claim 20 which includes, at least periodically, selecting an odd number of electrodes to constitute the group of electrodes, connecting a sub-group comprising an even number of active electrodes to one of the sources of RF energy and a sub-group comprising an odd number of active electrodes to the other of the sources of RF energy, with the active electrodes of the sub-groups alternating with one another 10 along a length of a catheter carrying the electrodes.;22. The method of claim 21 which includes selecting the group of electrodes to comprise at least three active electrodes which are energised simultaneously with the energy supplied to one sub-group comprising two outer active electrodes of the group;15 of three electrodes being in phase with each other but out of phase with the energy supplied to another sub-group comprising a single, inner active electrode arranged between the two outer electrodes of said one sub-group.;

23. The method of claim 22 which includes inteiposing a switching arrangement 20 between the secondary winding of the transformer and the group of electrodes periodically to change the configuration of electrodes connected to the sources of RF energy.;

24. The method of claim 22 or claim 23 which includes monitoring the energy 25 supplied to each active electrode.;

25. The method of claim 24 which includes monitoring and controlling the energy supplied to each active electrode by monitoring the temperature of each active electrode and selecting the hottest electrode for feedback control.;30;

26. The method of any one of claims 20 to 25 which includes connecting at least one active electrode to one sub-winding and connecting at least two active electrodes periodically to the other sub-winding.;INTELLECTUAL PROPERTY OFFICE OF N.Z.;2 4 DEC 2008 received;. 24/12 *2008 WED 10:32 FAX 61 2 8231 1099 FB RICE & CO @021/040 17

27. The method of any one of claims 20 to 26 which includes de-activating at least one of the electrodes connected to each source of RF energy at the time that at least one other electrode connected to that source of RF energy is active. 5

28. The method of claim 27 which includes activating a sub-group of electrodes of the group of the electrodes while the remaining electrodes of the group of electrodes are de-activated and, after a period of time, activating a different sub-group of electrodes. 10

29. The method of claim 28 which includes selecting the same number of electrodes to constitute each activated sub-group of electrodes.

30. A method of operating a heat-treatment device, the method including providing a transformer having a primary winding and a secondary winding, the secondary winding having at least one tap to provide a reference and at least two sources of radio frequency (RF) energy, the two sources of RF energy being out of phase with each other, and connecting a plurality of electrodes to the sources of RF energy provided by the secondary winding to be simultaneously energised, with multiple active electrodes being connected to one of the sources of RF energy and a different number of active electrodes being connected to the other source of RF energy; and supplying energy to each of the multiple active electrodes in the same phase and supplying energy to each of the different number of active electrodes out of phase with the energy supplied to the multiple active electrodes.

31. The method of claim 30 which includes supplying energy to each of the multiple active electrodes which has an amplitude less than the amplitude of the power supplied to each of the different number of active electrodes. 30

32. The method of claim 30 or claim 31 which includes connecting at least one active electrode to one sub-winding and connecting at least two active electrodes to the other sub-winding. :

33. A system for heating a site in a patient's body, the system substantially as described herein with reference to the accompanying drawings. INTELLECTUAL PROPERTY OFFICE OF N.Z. 2 4 DEC 2008 RECEIVED 15 20 25 . 24/12 (2008 WED 10:33 FAX 61 2 8231 1099 FB RICE & CO @022/040 18

34. A raethod of operating a heat-treatment device, the method substantially as described herein with reference to the accompanying drawings. INTELLECTUAL PROPERTY OFFICE OF ifZ. 2 4 DEC 2008 received